MedCity News April 16, 2024
Intra-Cellular Therapies reported its drug Caplyta met the main and secondary goals in the first of three pivotal studies in major depressive disorder. Success in two of them could support expanding the label of the drug, which is currently approved in schizophrenia and bipolar depression.
High placebo responses common in tests of neuropsychiatric drugs makes any clinical trial in major depressive disorder risky. Intra-Cellular Therapies now has data showing its drug met key goals of a pivotal clinical trial, beating a placebo in this indication. The results build the case for expanding the product’s label, which could push its sales into blockbuster territory.
According to the preliminary results reported Tuesday, the drug, lumateperone, led to statistically significant and clinically meaningful...
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